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FDA 510(k)

NEOCLOSE HASSON, NEOCLOSE UNIVERSAL

K-Number: K123280 · 2013-04-18

ApplicantNeosurgical, Ltd.
Decision Date2013-04-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEOCLOSE HASSON, NEOCLOSE UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Neosurgical, Ltd.. It received FDA 510(k) clearance on 2013-04-18 under 510(k) number K123280. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOCLOSE HASSON, NEOCLOSE UNIVERSAL?

NEOCLOSE HASSON, NEOCLOSE UNIVERSAL is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Neosurgical, Ltd.. The 510(k) number is K123280.

When did NEOCLOSE HASSON, NEOCLOSE UNIVERSAL receive FDA 510(k) clearance?

NEOCLOSE HASSON, NEOCLOSE UNIVERSAL received FDA 510(k) clearance on 2013-04-18, under 510(k) number K123280.

Who is the listed applicant for NEOCLOSE HASSON, NEOCLOSE UNIVERSAL?

The FDA 510(k) record lists Neosurgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOCLOSE HASSON, NEOCLOSE UNIVERSAL?

The FDA product code for NEOCLOSE HASSON, NEOCLOSE UNIVERSAL is GCJ.

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Other records listing Neosurgical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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